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BAF_FRontier-1LY4152199 for B-cell Malignancies After Prior Treatment

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What is being tested

LY4152199 - IV

Drug
Who is being recruted

Hemic and Lymphatic Diseases+9

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2026
See protocol details

Summary

Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2026

Actual date on which the first participant was enrolled.

This study is focused on evaluating a new medication called LY4152199 for adults who have previously been treated for B-cell lymphoma or leukemia. These are types of blood cancers that affect the B-cells, a kind of white blood cell. The goal is to assess how safe the drug is and how well it works in treating these cancers, especially for those who haven't found success with other treatments. Understanding the effects of LY4152199 could offer new hope and treatment options for patients facing these challenging conditions. The study involves two main parts. Initially, participants will help determine the best dose of LY4152199, ensuring it is both safe and potentially effective. In this phase, researchers will monitor participants closely for any side effects. Once the optimal dose is identified, the second part of the study will evaluate how well this dose works in treating specific types of B-cell cancers and leukemia. Participants will receive the drug and undergo regular health checks to see how their cancer responds to the treatment, providing essential data on its potential benefits and risks.

Official TitleBAF_FRontier-1, A First-in-Human, Phase 1 Trial to Assess Safety, Tolerability, and Preliminary Efficacy of LY4152199, a B-cell Activation Factor Receptor (BAFF-R) T-Cell Engager Bispecific Antibody in Adult Participants With Previously Treated B-cell Malignancies 
NCT07101328
Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

215 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, B-CellLymphoma, Large B-Cell, Diffuse

Criteria

16 inclusion criteria required to participate
Cohort C3: Mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), WM that has relapsed after or failed to respond to prior systemic treatment regimen.
Cohort C4: Chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) that has relapsed after or failed to respond to prior systemic treatment regimen.
Must have histologically confirmed diagnosis of relapsed/refractory B-cell malignancies as defined below per specific cohort.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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15 exclusion criteria prevent from participating
Pregnant and/or planning to breastfeed during the trial or within 90 days of the last dose of study intervention.
Active second malignancies, unless in remission, with life expectancy greater than 2 years with Sponsor approval.
Residual symptoms of neurotoxicity or cytopenias from prior chimeric antigen receptor T-cell therapy (CAR-T) or bispecifics. Exception: Cytopenia related to prior CAR-T or bispecifics allowed if they meet the adequate organ function criteria.
Known or suspected history of macrophage activation syndrome or hemophagocytic lymphohistiocytosis (HLH).
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Escalating doses of LY4152199 administered intravenously (IV)

Group II

Experimental
Two or more doses of LY4152199 (evaluated during dose escalation) administered IV

Group III

Experimental
Two or more doses of LY4152199 (evaluated during dose escalation) administered IV

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 50 locations

Suspended

City of Hope

Duarte, United StatesSee the location
Suspended

University of Colorado Denver - School of Medicine - Anschutz Medical Campus

Aurora, United States
Suspended

Colorado Blood Cancer Institute

Denver, United States
Suspended

Yale University School of Medicine - Yale Cancer Center

New Haven, United States
Recruiting soon50 Study Centers